HIPAA doesn't apply to Precision Medicine Initiative, sparking privacy concerns

A central concern to genomics is the aggregation of personal health information in one place. A report from the World Privacy Forum expounds upon this concern, and others, and suggests the federal government's Precision Medicine Initiative is too ambiguous and lax on its privacy guidelines.

Chief among the concerns is that medical record data and biospecimen data contributed to the initiative are not covered under HIPAA because the National Institutes of Health, which is spearheading the initiative, is not considered one of the three types of covered entities: healthcare providers, payers and healthcare clearinghouses.

The report cites a FAQ page from the NIH regarding the applicability of HIPAA to the NIH, which says, "NIH does not meet the definition of a 'covered entity' and is therefore not covered by HIPAA because it does not bill third parties for the healthcare they receive at the ClinicalCenter."

The report then mentions the Privacy Act of 1974, which "establishes a code of fair information practices that governs the collection, maintenance, use and dissemination of information about individuals that is maintained in systems of records by federal agencies." The act requires written consent of an individual to disclose any information about them, with the exception of certain cases. 

However, the report suggests this act may not be applicable to the Precision Medicine Initiative because a non-federal entity may operate the initiative. "We underscore that the Privacy Act of 1974 will not apply if NIH uses a grant instrument to fund PMI operations by a third party," according to the report.

This isn't to say the Precision Medicine Initiative is too unrestricted to proceed; rather, the report implores the government to be entirely transparent about the applicable legal protections.

"Before it launches, the PMI needs to clarify the legal and administrative privacy protections that apply to its activities," according to the report. "People who volunteer their medical data and biospecimens must be told what specific legal protections apply and do not apply."

More articles on precision medicine:

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7 genome sequencing, biobank projects in the news 

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